Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke
Authors: Qian Zhang, Anxin Wang, Qin Xu, Xue Xia, Xue Tian, Yijun Zhang, Xiaolong Li, Xiusheng Yang, Xingchen Wang, Jinghua Peng, Yanchun Li, Luran Liu, Shunshan Jin, Xia Meng, Xingquan Zhao, Yongjun Wang, Maolin He, Qiang Dong, Gang Zhao, Kangning Chen, Peng Xie, Yun Xu, Yi Yang, Li Guo, Yansheng Li, Yilong Wang, Xiaoli Zhang, Anding Xu, Xudong Pan, Cuilan Xiao, David Wang, Hao Li, Ying Gao, Jielai Xia, Hongjian Zhao, Huijuan Wang, Yue He, Weili Li, Xiangyang Wei, Junqing Bai, Shiwei Cao, Ying Song, Zhanhu Ma, Na Zhang, Nianzhen Yin, Long Zeng, Likun Zhang, Fang Yang, Jing Zhang, Jian Wang, Huili Tang, Yinghua Li, Hourong Zhou, Haisong Feng, Dongjing Song, Jianyu Wang, Yongcui Ma, Lihui Chen, Kaiwen Xiao, Qijin Zhai, Jing Li, Xiaojie Li, Yinqiao Yang, Xue Mei, Ziyun Zhu, Yan Zhang, Yuhu Liu, Hongxia Nie, Bing Fu, Gang Huang, Guoli Zeng, Bingrong Liu, Wang Xiaomin, Lianying Xu, Fan Zhang, Lan Wang, Wei Han, Shanshan Meng, Chang'e Xiao, Zhijie Yang, Yanqing Deng, Hu Ying, Li Tang, Chunli Jia, Chunpeng Li, Shihua Liu, Min Han, Yanhua Zhang, Feifei Peng, Jing Zhao, Donghai Qiao, Wenjing Li, Shengnan Cai, Qiuying Song, Chenghua Xiao, Ming Chen, Junjie Lei, Aimin Cai, Wenfang Xu, Jie Cao, Xinxin Liu, Dong Tan, Tao Feng, Feng Lina, Hongjing Yan, Changxia Liu, Yao Wang, Qinghua Yang, Lin Ji, Jing Xu, Liping Chen, Shuai Chen, Yanfeng Song, Li Mei, Sheng Ouyang, Jie Li, Defu Zhao, Zhaozuo Dong, Wei Jin, Guoxiang Tang, Na Geng, Hongxing Cai, Zaewang Li, Yu Chen, Li Huang, Yuzhang Zhang, Peng Lei, Mingmin Yan, Xiaojing Zhang, Yiqi Wang, Hailing Dou, Kun Wang, Guangjun Nie
Journal: JAMA Network Open (2023)

Importance Ginkgo diterpene lactone meglumine (GDLM) has attracted much attention because of its potential neuroprotective properties in ischemic stroke. The efficacy of GDLM in patients with acute ischemic stroke (AIS) needs to be verified by well-designed randomized clinical trials. Objective To assess the efficacy and safety of GDLM in patients with AIS. Design, Setting, and Participants This multicenter, randomized, double-blind, placebo-controlled, parallel-group trial involved 3448 patients who had AIS, were aged 18 to 80 years, had a clinically diagnosed AIS symptom within 48 hours of onset, had a modified Rankin Scale (mRS) score of 0 or 1 prior to onset, and had a National Institutes of Health Stroke Scale score ranging from 4 to 24. The trial took place at 100 centers in China from February 1, 2016, to May 1, 2018. The mRS is a global stroke disability scale with scores ranging from 0 (no symptoms or completely recovered) to 6 (death). The National Institutes of Health Stroke Scale is a tool used by clinicians to quantify impairment caused by stroke (range, 0-42, with higher scores indicating greater severity). Data were analyzed from January 2019 to December 2022. Interventions Patients were randomized to receive GDLM or placebo once daily via intravenous infusion in a 1:1 ratio. The treatment was dispensed within 48 hours after symptoms and continued for 14 days. Interventions of thrombolysis and thrombectomy were not permitted during the treatment. Main Outcomes and Measures The primary outcome was the proportion of patients with an mRS of 0 or 1 on day 90 after randomization. Safety outcomes included adverse events and serious adverse events. Results A total of 3448 patients were randomized, with 1725 patients assigned to the GDLM group and 1723 patients assigned to the placebo group. The median (IQR) age of the patients was 63 (55-71) years, and 1232 (35.7%) were women. The primary outcome on day 90 occurred in 877 patients (50.8%) in the GDLM group, and 759 patients (44.1%) in the placebo group (risk difference, 6.79%; 95% CI, 3.46%-10.10%; odds ratio, 1.31; 95% CI, 1.15-1.50; relative risk, 1.15; 95% CI, 1.08-1.24; P &amp;amp;lt; .001). Adverse events occurred relatively equally between the 2 groups (303 [17.6%] vs 298 [17.3%]; risk difference, 0.27%; 95% CI, −2.26% to 2.80%; odds ratio, 1.02; 95% CI, 0.85-1.21; relative risk, 1.02; 95% CI, 0.88-1.17; P = .83). Conclusions and Relevance Among patients with AIS in this randomized clinical trial, GDLM improved the proportion of patients achieving favorable clinical outcomes at 90 days compared with placebo. Trial Registration ClinicalTrials.gov Identifier: NCT02526225